5,946 IT Compliance jobs in India

We are seeking a highly skilled Regulatory Compliance professional to join our team in India. The ideal candidate will be responsible for ensuring that our organization adheres to all regulatory requirements and standards, thereby minimizing risk and promoting ethical practices.

• Ensure compliance with all relevant regulatory requirements in India.
• Review and interpret new and existing regulations and provide guidance to internal teams.
• Conduct risk assessments and compliance audits to identify potential compliance gaps.
• Develop and implement compliance policies and procedures to meet regulatory standards.
• Prepare and submit necessary reports to regulatory bodies as required.
• Provide training and support to staff on compliance matters.
• Collaborate with internal departments to ensure compliance is integrated into business processes.

• Bachelor's degree in Law, Business Administration, or a related field.
• 5-15 years of experience in regulatory compliance, preferably in the financial services or healthcare sectors.
• Strong understanding of Indian regulatory frameworks and compliance requirements.
• Excellent analytical and problem-solving skills.
• Ability to interpret complex regulations and provide clear guidance.
• Strong communication and interpersonal skills for collaboration with various stakeholders.
• Proficiency in compliance management software and tools.
• Detail-oriented with strong organizational skills.

Primary Job Function:

To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.

Core Job Responsibilities:

Position Accountability/Scope:

Minimum Education:

B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

Minimum Experience/Training Required:

Your key responsibilities

• Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. 
• Gather and analyse business requirements related to LIMS functionality and enhancements. 
• Analyse laboratory workflows and processes to recommend and implement LIMS solutions. 
• Translate business needs into functional specifications and system configurations. 
• Configure, test, and validate LIMS functionalities to meet business needs. 
• Conduct impact analysis and risk assessments for LIMS changes and enhancements. 
• Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. 
• Participate in business process mapping and workflow optimization to enhance LIMS utilization.
• Provide input on LIMS enhancements and new feature development to improve system performance. 
• Assist in troubleshooting, identifying, and resolving LIMS-related issues. 
• Conduct user training sessions and provide end-user support.
• Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. 
• Identify opportunities for automation and process improvement within laboratory operations using LIMS. 
• Master Data Design Configuration
• Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets.
• Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS.
• Maintain data integrity, consistency, and version control across the system. 
• Implement changes and updates to LIMS master data in alignment with business and regulatory needs. 
• Collaborate with cross-functional teams to ensure accurate data migration and system integration. 
• Troubleshoot and resolve issues related to master data configuration and system functionality. 
• Work on optimizing data structures and database management within LIMS. 
• Configurations & Customizations
• Develop, customize, and implement LIMS applications to meet laboratory and business requirements.
• Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. 
• Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. 
• Design and optimize databases for efficient storage and retrieval of laboratory data. 
• Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. 
• Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. 
• Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. 
• Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. 
• Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc.
• Stay up to date with new LIMS technologies, trends, and best practices. 
• Ensure system security, access control, and compliance with IT policies. 
• Provide ongoing support and maintenance for LIMS applications. 
• Engage in change management processes and drive adoption of new system functionalities. 
• Work with vendors and third-party providers to Configure, implement upgrades and enhancements. 
• Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines
• Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
• Review status updates and prepare management presentations.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Contribute to performance feedback for staff
• Foster teamwork and a positive learning culture 
• Understand and follow workplace policies and procedures
• Training and mentoring of project resources
• Cross skill and cross train the team members as per the business requirements 

Skills and attributes for success

• Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. 
• Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. 
• Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. 
• Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. 
• Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. 
• Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms).
• Knowledge of system integration with ERP, MES, or other enterprise applications. 
• Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. 
• Hands-on experience in master data configuration within LIMS platforms. 
• Experience in system validation, testing, and documentation. 
• Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization
• Understanding of relational databases and SQL queries. 
• Experience with scripting or automation tools for LIMS is a plus. 
• Understanding of API integrations, web services, and middleware solutions for LIMS. 
• Ability to troubleshoot system and data issues efficiently. 
• Strong problem-solving and analytical skills. 
• Excellent communication and stakeholder management abilities. 
• Ability to work independently and as part of a cross-functional team. 
• Strong attention to detail and commitment to data integrity. 
• Adaptability to dynamic business and regulatory environments. 
• Demonstrated track record in project management, governance, and reporting
• Exposure to Data Integrity requirements and other applicable regulations
• Knowledge of Incident Management, Change Management.
• Prior experience of supporting Audits / Inspections

To qualify for the role, you must have

• B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries.
• Good interpersonal skills; Good written, oral and presentation skills

Ideally, you'll also have

• Information Security (ISO 27001) or Risk Management certifications 
• LIMS admin certification or Equivalent
• Certified Scrum Master (CSM) or Equivalent (Preferred but not required).

The opportunity

We’re looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

Skills and attributes for success

To qualify for the role, you must have

Ideally, you’ll also have

What we look for

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.
You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

EY | Building a better working world 

EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you'll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

We're looking for Senior with expertise in Computer System Validation and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering.

Your key responsibilities

• Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach
• Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc.
• Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions.
• Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach
• Perform Software classification, IT risk assessment and Mitigation strategies for IT applications.
• Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement
• Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner.
• Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents.
• Demonstrate team work by working with cross functional teams across service lines in completing the deliverables within the timelines
• Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business.
• Review status updates and prepare management presentations.
• Actively contribute to improving operational efficiency on projects & internal initiatives.
• Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines.
• Contribute to performance feedback for staff
• Foster teamwork and a positive learning culture
• Understand and follow workplace policies and procedures
• Training and mentoring of project resources
• Cross skill and cross train the team members as per the business requirements

Skills and attributes for success

• Prior experience of leading quality and compliance projects in Regulatory Compliance.
• Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc.
• Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC
• Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization
• Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc.
• Demonstrated track record in project management, governance, and reporting
• Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc.
• Exposure to Data Integrity requirements and other applicable regulations
• Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures
• Prior experience of supporting Audits / Inspections
• Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance
• Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems
• Hands on experience of preparing validation deliverables for software implementation projects
• Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,

To qualify for the role, you must have

• B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies
• Good interpersonal skills; Good written and presentational skills

Ideally, you'll also have

• Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA)
• ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA)
• Information Security or Risk Management certifications

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

Your Key Responsibility:

• Collaborate with stakeholders to gather requirements and define software functionalities and limitations.
• Design and develop software applications on the EtQ Reliance platform based on business requirement while working with an Agile team
• Configure or customize the EtQ Reliance system to meet business needs.
• Conduct unit testing to ensure software quality and performance.
• Peer review of code/configurations.
• Create and maintain technical documentation, including system configurations and workflows.
• Perform promotions of solution to higher environments while following business defined SDLC process.
• Create and execute test scripts to qualify code promotions (IQ/OQ)
• Provide technical support and training to end-users on the EtQ Reliance system as needed.
• Troubleshoot and resolve issues and bugs in the production environment while supporting root cause analysis and impact assessments. 
• Collaborate with technical leads, scrum masters to define project scope, timelines, and deliverables and follow Agile process.
• Stay up-to-date with the latest EtQ Reliance features, functionalities, and industry trends.

To qualify for the role, you must have

• Bachelor's degree in Computer Science, Software Engineering, or a related field.
• Strong background in coding with Python and Java
• Strong background in Advanced SQL and DBMS
• Strong knowledge of the EtQ Reliance platform and its modules.
• Excellent problem-solving and analytical skills.
• Previous experience as an EtQ Developer including: 
• Exposure to basic configurations to setup workflows, forms, views, notifications.
• Exposure to advanced configurations and customizations in ETQ using ETQScript.
• Experience with handling internal and external system integrations in ETQ
• Experience with creating custom Views by leveraging multi-valued fields spread across multiple forms and creating embedded views within forms in ETQ
• Experience with creating and maintaining scheduled jobs to enable automation and system integrations in ETQ
• Understanding of Master Keyword List and Master Names List and how to create and maintain them in Reliance
• Experience with using office integration tool to integrate MS Office with ETQ Reliance forms
• Access control in ETQ Reliance - define and maintain access roles and user groups in Reliance
• Experience with data migration in ETQ with knowhow of data migration best practices when operating in a regulated environment
• Ability to work independently and manage multiple priorities while following Agile methodology
• Strong communication and collaboration skills.

Good to have:

• ETQ Reliance Promotion Certification
• Intermediate or Advanced ETQ Designer certification

Job Description

Opportunity : Our Advisory Services team provides custom advisory services to clients including hedge funds, private equity, fund of funds, real estate, venture capital, family offices, wealth management firms, and broker/dealers. We utilize our deep expertise in finance, accounting, compliance, fund administration, operations, and due diligence to support various aspects of our client’s non-investment business function. Our team successfully ensures that projects are executed efficiently and in accordance with industry leading practices and regulatory requirements.

Within this role you will have the opportunity to participate in various projects including, but not limited to Operational Due Diligence Assessments, Loan Transaction Review, Due Diligence Questionnaire and Policy Creation Support Services, Project Management, Strategic Development, Launch and Winddown Advisory, and Corporate Secretarial Services. This breadth of work allows individuals on our team to find their niche and apply themselves in those areas.

A strong Operational Due Diligence background lends itself to several other projects for which our group is engaged.

Role-Specific Accountabilities:

Regulatory Compliance Manager will be responsible for managing the continued development and implementation of a global trade compliance program.

Investigative skills will be applicable in managing trade compliance with other countries, as needed.

Acting as a regional trade compliance representative, you will maintain an active role in assuring compliance of import/ export activities in the company owned subsidiaries and offices in APJ. In respect of Customs regulations and import/export licence controls.

Apply continuity with the global trade compliance programs by country.

You will be responsible for identifying, prioritizing and addressing trade compliance risk and Customs compliance risk.

The initial focus of the Regulatory Compliance Manager is Export Control matters. This includes resolving potential DPL matches, transactional work with stakeholders, review of compliance holds on strategic or controlled goods-based end use/end user. The Regulatory Compliance Manager is responsible for collating and analyzing metrics related to export controls. The job will also involve supporting integration of systematic export controls into ERP systems. The role will develop and extend into areas of Customs (import/export) operational controls and will be responsible for process improvement and productivity improvements in that area.

• Be a subject matter expert and escalation person for matters related to trade compliance – export control, sanctions, Customs compliance.

• Be a facilitator to design and implement improved trade compliance programs working with vendors, brokers, and related internal and external business partners.

• Communicating and meeting with relevant Government authorities as needed.

• Complete timely and compliant transaction controls and reviews.

• Prepare and present relevant data analytics to support decision making

• Backup other APJ Trade Compliance activities, if required.

• The role will not line manage staff

• 5 to 8 Years of relevant international trade, import and export experience.

• University Degree or equivalent. Major in Legal, International Trade, Logistics or relevant preferred. Optional for candidates who has more relevant experience.

• Experience on Technology sector.

• Good technical and practical knowledge in customs and export control regulations in India, experience in Asia Pacific is a plus.

• Knowledge of US Export Administration Regulation and APJ Import and Export regulations.

• Operates without supervision within established guidelines.

• High level of independent thinking and problem-solving capabilities

• Able to identify and address potential risk at trade compliance

• Good IT skills (Microsoft office applications etc.).

• Able to provide interpretation of Regulations to internal and external business partners

• Able to converse and write effectively in English. Able to speak/ read in second language with Asia Pacific is an advantage but not mandatory.

• Possesses strong multi-cultural interpersonal skills.

• Able to constructively work under stress and pressure when faced with high workloads and deadlines.

• Able to maintain and promote social, ethical, and organizational standards in conducting internal and external business activities.

• Able to maintain confidentiality of sensitive information.

• Able to build solid, effective working relationships with others.

• Able to exhibit ability to be sensitive to the needs, concerns, and feelings of others.

• Able to quickly learn new systems and technology.

• Consistent non-standard work or overtime as business requires.

• On-call availability required as necessary.

• Professional, office environment.

• Full-time working week with some work hours flexibility expected

What’s In It For You?

• Elective Benefits: Our programs are tailored to your country to best accommodate your lifestyle.
• Grow Your Career: Accelerate your path to success (and keep up with the future) with formal programs on leadership and professional development, and many more on-demand courses.
• Elevate Your Personal Well-Being: Boost your financial, physical, and mental well-being through seminars, events, and our global Life Empowerment Assistance Program.
• Diversity, Equity & Inclusion: It’s not just a phrase to us; valuing every voice is how we succeed. Join us in celebrating our global diversity through inclusive education, meaningful peer-to-peer conversations, and equitable growth and development opportunities.
• Make the Most of our Global Organization : Network with other new co-workers within your first 30 days through our onboarding program.
• Connect with Your Community: Participate in internal, peer-led inclusive communities and activities, including business resource groups, local volunteering events, and more environmental and social initiatives.